Product Safety Recalls

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WATER Recall D-1031-2022

Description: Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06

WATER Recall D-1031-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1031-2022
Event ID89646
Generic NameWATER
Original Package?1
Active SubstanceWATER
DistributionUSA nationwide.
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0338-0013
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier059QF0KO0R
Drug Application NumberNDA018632
Structured Product Labeling (SPL ID)38e6f41f-36c5-47c9-857a-eaa2fc137eb3
Structured Product Labeling (SPL Set ID)210dc9ab-d6ca-4552-ac19-1be17792d290
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